ZebraSci is pleased to announce the acquisition of a PTI 455 Vacuum Decay Leak Testing system. This state of the art platform is a robust and reliable solution for ensuring Container Closure Integrity (CCI) for critical parenteral applications.
Vacuum decay is a proven non-destructive test method. The principle behind vacuum decay leak testing make it one of the most simple and effective package integrity tests.
The leak tester connects to a test chamber that is specifically designed to contain the package to be tested. The test is performed by placing a package into the test chamber, drawing vacuum on the test chamber and monitoring it for any changes in the vacuum level. If a package is defective, air or vapor will leak from the package into the test chamber causing a change in pressure. Non-leaking packages do not leak any air into the chamber, holding the chamber vacuum level constant. The test cycle takes only a few seconds, is non-invasive and non-destructive to both product and package.
“Many of you know that Vacuum Decay is an excellent CCI test method for parenteral packaging filled with air, dry products and many small molecule liquids” said Eric Creveling, Director of Laboratory Services, ZebraSci, “but PTI’s vacuum decay technology is flexible – systems can be designed to quickly and reliably evaluate rigid, semi-rigid and flexible packaging made of non-porous or porous materials. Similar to our own inspection equipment, another benefit of PTI’s technology platform is that it scales from lab to manufacturing, ensuring product quality throughout the product lifecycle.”
The standard vacuum decay leak test method (ASTM F2338) has long been recognized by the FDA as a consensus standard for package integrity testing. The test method is also listed in ISO 11607 and referenced in the United States Pharmacopeia Chapter on CCI – USP <1207>.
ZebraSci’s experienced engineers are well versed in vacuum decay and other highly sensitive CCI methods. We can guide you to the best approach for your product/package combination from parental applications to sterile barrier materials. Contact us today to learn more about applications for Vacuum Decay and our other solutions for Container Closure Integrity.